Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 10
- 主要终点
- Mean Change From Baseline in Maximum Keratometry (Kmax)
研究概览
简要总结
Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.
详细描述
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ectasia after refractive surgery
- •Documented ectasia on Pentacam or topography map
- •BSCVA worse than 20/20
- •Must complete all study visits
排除标准
- •History of delayed wound healing
- •History of corneal melt or corneal dystrophy
研究组 & 干预措施
Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation
干预措施: riboflavin ophthalmic solution (Drug)
Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation
干预措施: UVA Irradiation (Device)
Control Group
riboflavin opthalmic solution without UVA irradiation
干预措施: riboflavin ophthalmic solution (Drug)
结局指标
主要结局
Mean Change From Baseline in Maximum Keratometry (Kmax)
时间窗: baseline,12 months
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
次要结局
未报告次要终点